Today, many patients recovering from operations or suffering from medical ailments, are permitted (or required) to complete their recovery or undergo medical treatment at home, thereby providing a more comfortable environment for the patient and reducing the cost of the treatment. This trend has also led to the increase in the use of home health care equipment for facilitating in the patient's recovery. This equipment can include oxygen and oxygen delivery systems as well as ambulatory pumping and other dispensing devices for delivering prescription medicines and other substances.
While such home health care recovery and rehabilitation programs can save money and have other advantages, they had a disadvantage in that the health care provider was required to make a trip to the home of the patient in order to monitor and/or change the operation of the home health care device, or to gather data regarding the operation of the device. For example, if the prescription for the patient was to be changed, the health care provider needed to physically travel to the home of the patient and reprogram the drug delivery dispenser.
Accordingly, systems have been developed which allow for the remote access by the health care provider to the in-home health care device, and which thereby allow the health care provider to interrogate, monitor and/or program the device from a location which is remote with respect to the patient's home (e.g., a health care facility). These programs also allow the provider to monitor the operation of the pump from this remote location. For example, the VERIFUSE PLUS.TM. delivery system with the VOICE LINK.RTM. communications feature, marketed by the I-Flow Corporation, allows the health care provider to communicate with a pump from anywhere using a touch tone telephone. The voice communication software resides in the patient's pump and guides the health care provider through the programming steps via a voice mail system. The system also allows the health care provider to diagnose an alarm status from a remote location, as well as to change existing programs for the medical equipment.
U.S. Pat. No. 5,338,157, issued to Blomquist, discloses another system and method for communicating with transportable medical devices, and in particular, with drug pumps. In one embodiment, a communication system is provided where a remote drug pump communicates with a similar local drug pump over telephone communication lines, such as through modems, for example. Each of the drug pumps are provided with a pump controller for controlling the operation of the pump, and the controller may include a processor and associated memory for storing operating programs and other information. Each drug pump can include an operator input mechanism for making inputs to the controller, as well as a display mechanism for displaying information about operations of the pump. When communication has been established between the pumps, the caregiver pump can be used by the caregiver for data gathering, trouble shooting, and operational program changes with respect to the remote patient pump. In another embodiment, the controller for the pump is put into a "locked" status through an access code program which prevents the patient from altering the pump operations program or from accessing other pump information in the memory.
While the device disclosed in this patent provides some security for preventing the patient from altering the patient pump program, the security means disclosed lacks certain capabilities. For example, no security mechanism is provided in the patent for ensuring that only the appropriate patient can use the remote medical equipment. Thus, an unauthorized individual can apparently begin use of the remote medical equipment and thereby damage the equipment, or injure themselves or the patient. Moreover, the patent does not describe a means for ensuring that only those particular caregivers who are in charge of the particular patient are permitted to communicate with the patient's remote medical equipment. Thus, an unauthorized caregiver in the caregiver facility might sign on and accidentally or intentionally change the remote pump program thereby endangering the patient. Moreover, this individual might gain unauthorized access to personal data regarding the patient or their medical device.
In addition, the devices described above do not provide means for saving the operation program (i.e., the "prescription") and historical operation data for the medical device in a convenient and portable form, such that the patient can easily transport the program with them for use at other locations or health care facilities. While prior art devices can be reprogrammed with new prescription programs for use with a different patient, such a reprogramming process can be time consuming and requires knowledge of the functions and structure of the particular device being reprogrammed.
Moreover, the systems and devices of the prior art do not provide a means for monitoring the operation of the medical device and saving the data regarding these operations in a convenient and portable medium. While prior art devices allow such data to be collected and saved, the data has not been provided on a medium that can easily and safely be carried by the patient, such as might fit in the patient's wallet, so that the patient may keep the data on his or her person at all times.
Accordingly, to overcome the above and other problems, it is desirable to provide portable medical devices that are operated in a secure manner, such that only authorized patients can use the device. In addition, it is desirable to allow remote control access to such devices in a controlled and secure manner, such that only those care providers treating the patient can access the data and programs associated with the device. Moreover, it is desirable to provide the control programs and data associated with such devices in a convenient and portable format, such that the programs and data can be easily transferred from one device to another, without the need for extensive reprogramming. Moreover, it is desirable to provide a paperless recording system for recording the operational data associated with in-home medical devices in a format that can be easily kept with the patient at all times.